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Trial Summary

GoTHAM is intended as a signal-seeking, biomarker, phase Ib/II study that will evaluate the safety and anti-tumour activities of the novel combination of avelumab with 177-Lu-DOTATATE (a type of peptide receptor radionuclide therapy; PRRT) or external beam radiation therapy (EBRT) in patients with metastatic Merkel cell carcinoma (mMCC).

Acronym:

GoTHAM

ACTRN/NCT /ethics:

NCT04261855

Scientific title:

TarGeted THerapy and Avelumab in Merkel Cell Carcinoma 10.17 The GoTHAM Study. A phase Ib/II study of combination avelumab with peptide receptor radionuclide therapy or conventional fractionated radiotherapy in patients with metastatic Merkel cell carcinoma

Sponsor / Cooperative group:

Melanoma and Skin Cancer Trials Limited

Trial & Patient Characteristics

Cancer TypeMelanoma & other skin
Trial TypeTreatment
PhasePhase I, Phase II
Age Range18 years and older
SexAll
Tumour Stream -
Cancer StageMetastatic or Widespread
Anticipated Start Date2020-10-08
Anticipated End Date2024-01-01

Participating Hospitals

HospitalRoyal Adelaide Hospital
Clinical Trial CoordinatorAnne Milton
Emailanne.milton@sa.gov.au
Phone08 7074 2342
Principal InvestigatorProfessor Michael Brown
Recruitment StatusRecruiting